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Complimentary Webinar

March 12, 2021 | 1:00 p.m. - 2:00 pm EDT

Medical Device Regulation - MDR Transition Update

In this webinar, Korina Akhondzadeh and Robert Dostert, will cover the key points to be aware of during your migration to the MDR. This overview will help you prepare for the date of application (May 26, 2021), the expectations and requirements to be met. Key points covered will include classification rules, technical documentation, economic operators, and post market surveillance.  

Learning Objectives:

With the application date fast approaching, gain insights into the new MDR requirements. Following the webinar, you will be better prepared to meet the increased requirements that have been placed on medical device manufacturers. You will gain an understanding of your next steps, whether it is additional MDR transition training, or what to discuss with your notified body.

SPEAKERS

Robert Dostert
Sales Manager
DNV GL

Robert has 20 years of experience in the Healthcare industry. At DNV GL, Robert collaborates with a team of more than 150 experts, who serve the medical device industry worldwide. Robert is driven to ensure DNV GL's clients are provided quality services including assessments, CE Marking, software tools, training, and technical expertise to successfully bring their products to the healthcare market in a safe and timely manner.

Korina Akhondzadeh
Principal/Sr. Regulatory Consultant
KARA & Associates, Inc.

Prior to joining KARA & Associates in 2003, Korina worked for many notified bodies, as well as medical device manufacturers in regulatory affairs and quality assurance roles. She was responsible for a variety of RA/QA functions, including ensuring compliance with FDA QSRs (21 CFR Section 820), EU regulations and other international regulations. Her work included auditing, international submissions and FDA 510(k) preparations, product registrations, training, ISO implementation and CE Marking requirements. Korina holds a Bachelor’s degree in Public Relations and actively speaks on regulatory topics for various national, as well as international organizations, such as: RAPS, AMDM, SDRAM, USC, SDSU and others. Korina is a qualified training instructor for the MDR by numerous notified bodies.

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